The REKINDLE Study for Adjustment Disorder

Clinical Trial Title The REKINDLE study for those experiencing mental health distress due to serious medical illness: A study of an investigational single-dose, short-acting psychedelic medication for adjustment disorder

National Clinical Trial Number: NCT07002034

Clinical Trial Protocol Description:

If you are experiencing mental health distress due to cancer or other serious medical illness, the REKINDLE Study for Adjustment Disorder may be an option. The study is testing an investigational single-dose, short-acting psychedelic medication to see if it can help people with symptoms of depression with or without anxiety linked to adjustment disorder due to a serious medical illness.

Participation in the REKINDLE Study is voluntary. Interested potential study participants will be screened at a study center where they will be assessed to ensure they can participate safely. During the screening process, study participants will also meet and get to know their session monitors, professionals trained to guide and stay with them during their investigational dosing experience. Participants will receive a single subcutaneous injection of the study medication at the study center and will be monitored in a comfortable environment. Study participants will have a 50/50 chance (like the flip of a coin) of being assigned to either a high dose or low dose of the study drug.

After dosing, study participants will be followed for six additional weeks to evaluate their symptoms and check on their safety. Including a screening period of up to 28 days, the 1-day dosing visit and a 6-week post-dose follow-up period, participation in this study will last up to ten weeks.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Are between 18 and 80 years of age.
Have been diagnosed with cancer (stages 1-4), or other serious conditions such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson’s disease (PD), or idiopathic pulmonary fibrosis (IPF).
Are experiencing symptoms of depression, with or without anxiety, and feelings of being overwhelmed for at least four weeks.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.